E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10018337 |
E.1.2 | Term | Glioblastoma multiforme |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
• Local and systemic safety and tolerability of the IMP,
• Maximum tolerated dose (MTD) of the IMP,
• Viremia following administration of the IMP,
• Virus shedding/persistence following administration of the IMP.
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E.2.2 | Secondary objectives of the trial |
• Proof of Concept (PoC) in subjects with progressive/recurrent GBM,
• Progression-free Survival (PFS) up to 6 months after study inclusion,
• Overall survival (OS).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age over/equal 18 year,
2. Diagnosis of glioblastoma multiforme,
3. Written informed consent,
4. Recurrent or progressive disease despite previous radio- and/or chemotherapy,
5. Indication for complete or subtotal tumor resection,
6. Life expectancy of at least 3 months,
7. Consent for sampling and investigation of biological specimens,
8. Karnofsky Performance Score over/equal 60,
9. Adequate seizure control,
10. Adequate bone marrow function: neutrophils >1.5 x 109/L, platelets >100 x 109/L, hemoglobin >9.0 g/dL,
11. Adequate liver function: Bilirubin <2.0 g/dL, ASAT, ALAT, AP, GGT <3 x ULN,
12. Adequate renal function: Creatinine <1.8 g/dL,
13. Adequate blood clotting: aPTT <35 sec, INR <1.2,
14. Negative serology for HIV, HBV and HCV,
15. Negative Beta-HCG test in women of childbearing potential,
16. Commitment to use adequate contraception (in both genders) for up to six months after study entry,
17. Commitment to omit exposure to infants <18 months of age or immunocompromised individuals for up to 28 day after first administration of IMP.
18. Only for Group III: feasibilitly of intratumoral injection of 2.5 mL IMP |
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E.4 | Principal exclusion criteria |
1. Multifocal disease,
2. Evidence of distant tumor metastases,
3. Contraindications for MRI,
4. Active infection within 5 days prior to the study inclusion,
5. Chemotherapy within 4 weeks prior to the study inclusion,
6. Radiotherapy within 6 weeks prior to the study inclusion,
7. Participation in another interventional trial within the last 30 days,
8. Treatment with antiangiogenic substances within 21 days prior to therapy
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E.5 End points |
E.5.1 | Primary end point(s) |
• Local and systemic safety and tolerability of the IMP,
• Maximum tolerated dose (MTD) of the IMP,
• Viremia following administration of the IMP,
• Virus shedding/persistence following administration of the IMP
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Up to 28 days after the first administration of the IMP |
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E.5.2 | Secondary end point(s) |
• Proof of Concept (PoC) in subjects with progressive/recurrent GBM,
• Progression-free Survival (PFS) up to 6 months after study inclusion,
• Overall survival (OS).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Up to 6 months after the first daministration of the IMP |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
immunology and proteomics of glioblastoma |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | Yes |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit 6 months after the first administration of the IMP |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |